Commission Directive 2005/28/ECShow full title

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance)

Article 17U.K.

The sponsor and the investigator shall retain the essential documents relating to a clinical trial for at least five years after its completion.

They shall retain the documents for a longer period, where so required by other applicable requirements or by an agreement between the sponsor and the investigator.

Essential documents shall be archived in a way that ensures that they are readily available, upon request, to the competent authorities.

The medical files of trial subjects shall be retained in accordance with national legislation and in accordance with the maximum period of time permitted by the hospital, institution or private practice.